ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF QUINIDINE IN PHARMACEUTICAL DOSAGE FORMS BY USING RP-HPLC METHOD

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A. Srivani, K.Sudhakar, Dr.S.Srinivasa Rao, G.Monika, T.Supriya

ABSTRACT: The Present work was to develop a simple, fast, accurate, precise, reproducible, Reverse Phase High Performance Liquid Chromatographic Method for estimation of Quinidine in pure drug form. Chromatographic separation was done using Terrosil C18 column having dimension of (100 mm x 4.6 mm) having particle size of 5.0 µm, with mobile phase consisting of Phosphate buffer (KH2PO4) pH 3 ±0.02 pH adjusted with ortho phosphoric acid and Acetonitrile  (25:75 %v/v), flow rate was adjusted to 0.8 ml/min and detection wavelength at 254nm. The retention times of Quinidine was found to be 2.589. The proposed method has been validated for accuracy, precision, linearity; robustness and range were within the acceptance limit according to ICH guidelines. Linearity for Quinidine was found in range of 20µg/ml-60µg/ml and correlation coefficient was found to be 0.999 ,%RSD for intermediate precision was found to be 0.1, for repeatability was 0.2 ,% mean recovery for Quinidine was found to be 99.77%. The method was found to be robust even by change in the mobile phase ±5% and in less flow condition. The developed method can be successfully employed for the routine analysis of Quinidine in API and Pharmaceutical dosage forms.

Method development, Validation, Quinidine, Dosage forms.